The Evera MRI SureScan ICD is licensed for MRI scans when needed on any part of the body, according to Fridley, Minn-based Medtronic. The licensing includes both the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be MRI-conditionally cleared.
“The Evera MRI ICD system underwent comprehensive computer modeling of more than 2.3 million clinical scenarios and this information, combined with the safety data from the clinical trial, has resulted in this important regulatory license. As pioneers in the development of implantable cardiac devices that can be used in an MRI environment, Medtronic is committed to ongoing innovation to address the clinical needs of physicians and patients,” Medtronic Canada prez Neil Fraser said in a press release.
Clearance was based on safety and efficacy data from Medtronic’s Evera MRI clincial trial. The 275-patient, 42-center trial demonstrated the system as safe and effective, even after MRI scans, and data from the study was published in the Journal of the American College of Cardiology, Medtronic said.
“This is a very important advancement in the medical field since a significant percentage of ICD patients will eventually require an MRI for cardiac imaging modalities and for other organ imaging,” Montreal Heart Institute’s Dr. Blandine Mondésert said in prepared remarks.
In September, the FDA granted pre-market approval for its Evera MRI SureScan device, which Medtronic touted as the 1st MRI-safe implantable cardiac defibrillator to win U.S. approval.
The Evera MRI SureScan won CE Mark approval in the European Union in April 2014, the same month that Medtronic launched a U.S. investigational device exemption trial for the device.